Randomized double-blind clinical trial comparing clobetasol and dexamethasone for the topical treatment of symptomatic oral chronic graft-versus-host disease.

Patients who undergo allogeneic stem cell transplantation frequently develop an immunologic disease caused by the reactivation of the graft to the host tissues. This disease is called graft-versus-host disease (GVHD) and it is usually a systemic disorder. In a large proportion of cases, oral disorders that are related to a chronic phase of GVHD (cGVHD) occur, and their treatment involves the use of topical immunosuppressive drugs. Several medications have been studied for this purpose, but only a small number of clinical trials have been published. The present study is a randomized, double-blind clinical trial that compares topical clobetasol and dexamethasone for the treatment of symptomatic oral cGVHD. Patients were randomly assigned to treatment with clobetasol propionate .05% or dexamethasone .1 mg/mL for 28 days. In both arms, nystatin 100,000 IU/mL was administered with the corticosteroid. Oral lesions were evaluated by the modified oral mucositis rating scale (mOMRS) and symptoms were registered using a visual analogue scale. Thirty-five patients were recruited, and 32 patients were randomized into the study groups: 18 patients (56.3%) to the dexamethasone group and 14 patients (43.8%) to the clobetasol group. The use of clobetasol resulted in a significant reduction in mOMRS total score (P = .04) and in the score for ulcers (P = .03). In both groups, there was significant symptomatic improvement but the response was significantly greater in the clobetasol group (P = .02). In conclusion, clobetasol was significantly more effective than dexamethasone for the amelioration of symptoms and clinical aspects of oral lesions in cGVHD.

Oral involvement of chronic graft-versus-host disease in hematopoietic stem cell transplant recipients.

Oral manifestations are common in patients who are diagnosed with chronic graft-versus-host-disease (cGVHD). These manifestations can present as oral mucosal lesions, salivary gland dysfunction, or reduction of the mouth opening due to cutaneous sclerosis. Although several studies have reported the prevalence of oral involvement in cGVHD, few have reported details of different types and severity of oral lesions of cGVHD, according to the NIH. Furthermore, the authors are aware of only one published study concerning oral manifestations of cGVHD in Brazil. The purpose of this study was to evaluate the prevalence and severity of oral involvement of cGVHD. Oral evaluation of hematopoietic stem cell transplant (HSCT) recipients was conducted on 22 patients (12 men and 10 women) from December 2007 to May 2009. The following categories were assessed: Age, gender, underlying disease, time postHSCT, history of GVHD, therapy for GVHD, oral lesions, xerostomia, resting salivary flow rate, and mouth opening. Oral lesions were classified according to NIH criteria, and the results were submitted to a descriptive analysis. According to the NIH, patients presented diagnostic (40.9%), distinctive (31.9%), and common (9.1%) features of oral cGVHD. Oral involvement of cGVHD was identified in 81.8% of patients, 68.2% as mucosal lesions and 59.1% as salivary gland dysfunction. Reduced mouth opening was observed in 12 patients (80%), with one case associated with cutaneous sclerosis. Oral involvement was frequent in these patients; for many, it was the first clinical manifestation of cGVHD.

Diretrizes para o diagnóstico, classificação, profilaxia e tratamento da doença enxerto contra hospedeiro crônica / Guidelines for the diagnosis, classification, prophylaxis and treatment of chronic graft-versus-host disease

A falta de critérios diagnósticos padronizados, amplamente utilizados, pode comprometer tanto a avaliação real da incidência da doença contra hospedeiro crônica bem como a correlação de sua gravidade com a taxa de mortalidade pós-transplante. Na I Reunião de Diretrizes da Sociedade Brasileira de Transplante de Medula Óssea, realizada em junho de 2009, o Grupo de Estudos de DECH Brasil - Seattle (GEDECH), baseado na realidade dos Centros brasileiros, apresentou as recomendações para diagnóstico, classificação, profilaxia e tratamento da doença enxerto contra hospedeiro crônica propostas pelo National Institutes of Health. Estas propostas incluíram padronização das características utilizadas no diagnóstico e ferramentas para a pontuação dos órgãos envolvidos e avaliação global da gravidade a serem utilizados em estudos clínicos da doença enxerto contra hospedeiro crônica. Estes critérios são úteis para uma melhor análise da incidência desta doença, além de poder avaliar a gravidade do comprometimento de um órgão ou sítio envolvido e a influência na mortalidade tardia do transplante. A profilaxia e os tratamentos propostos para esta importante complicação dos transplantes de células-tronco hematopoéticas foram discutidos e graduados de acordo com níveis de evidência estabelecidos pelo National Institutes of Health.

The lack of widely-used standardized diagnostic criteria may impair both the true evaluation of chronic graft-versus-host disease and the correlation of its severity with transplant-related mortality. At the I Consensus of the Brazilian Society of Bone Marrow Transplantation - SBTMO that took place in June 2009, the Group of GVHD Studies Brazil-Seattle (GEDECH), presented the guidelines for diagnosis, classification, prophylaxis and treatment of chronic GVHD as proposed by the National Institutes of Health and based on the reality in Brazilian Centers. These proposals, including standardization of features used in diagnosis and tools to score involved organs and to assess the overall severity, should be used in clinical studies of chronic graft-versus-host disease. These criteria are useful to better analyze the incidence of this disease, in addition to evaluate the extension of the involvement of organs or the site affected and its influence on late transplantation mortality. Prophylaxis and treatment proposed for this important complication of hematopoietic stem cell transplantations were discussed and graded according to the levels of evidence established by the National Institutes of Health.